MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA2; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Catalog Number	05168449190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the first c701 analyzer was provided as (b)(6).The serial number of the second c701 analyzer was requested, but not provided.The customer programmed additional carryover washes on the analyzers.The field service engineer performed precision studies and these were not acceptable.Performance testing was also not acceptable.The engineer checked the filling of the cuvettes, the gear pump pressure, and the incubation bath window, but there were no problems.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for an unspecified number of patient samples tested with ca2 (calcium) on two cobas 8000 701 module analyzers.Some results were found to be too low and others were too high.The customer noted that doctors have been complaining that calcium values are too high.An example was provided for one patient sample with discrepant calcium results.The sample initially resulted in a calcium value of 3 mg/dl when tested on a first c701 analyzer.The sample was repeated on the second c701 analyzer, resulting in a calcium value of 8 mg/dl.
Additional Manufacturer Narrative
Calibration data from both analyzers showed issues since (b)(6) 2023.The last calibration was successful.Quality control data from (b)(6) 2024 to (b)(6) 2024 was within range.A general analyzer performance issue could be ruled out.Upon review of the alarm trace, there were multiple foam detection alarms and alarms indicating low incubation water level.Multiple abnormal aspiration alarms were observed (b)(6) 2024 to (b)(6) 2024.It was determined that the customer stores their samples at high room temperatures for several hours.Elevated calcium values often came from samples that had been stored for several days.After 3 days of storage, calcium values increase due to evaporation.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• Brand Name: CA2
• Common Device Name: TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18874863
• Report Number: 1823260-2024-00722
• Device Sequence Number: 12742452
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K113521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 05168449190
• Device Lot Number: 73362001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown